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A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

Primary Purpose

Multiple Myeloma, Autologous Stem Cell Transplant

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ixazomib Citrate
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug therapy, Ixazomib citrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria.
  2. Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available.
  3. Underwent standard of care (SOC) induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], and dexamethasone (VAD) is not an acceptable induction therapy for this trial.
  4. Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.
  5. Must have not received post-ASCT consolidation therapy.
  6. Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.
  7. ECOG performance status of 0 to 2.

  8. Female participants who:

    • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, AND
    • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
    • Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, AND
    • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
    • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
  9. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
  10. Suitable venous access for the study-required blood sampling.
  11. Is willing and able to adhere to the study visit schedule and other protocol requirements.

  12. Must meet the following clinical laboratory criteria at study entry:

    • Absolute neutrophil count (ANC) ≥ 1,000 per cubic milliliter (/mm^3) and platelet count ≥ 75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization.
    • Total bilirubin ≤ 1.5 * the upper limit of the normal range (ULN).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 * ULN.
    • Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min).

Exclusion Criteria:

  1. Multiple myeloma that has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy.
  2. Double (tandem) ASCT.
  3. Radiotherapy within 14 days before the first dose of study drug.
  4. Diagnosed or treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.
  6. Major surgery within 14 days before randomization.
  7. Central nervous system involvement.
  8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.
  9. Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
  10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
  11. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study.
  12. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
  13. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).
  14. Psychiatric illness/social situation that would limit compliance with study requirements.
  15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
  17. Treatment with any investigational products within 60 days before the first dose of the study drug regimen.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • Mayo Clinic - PPDS
  • Montefiore Medical Center
  • Penn State Health Milton S. Hershey Medical Center
  • Baylor University Medical Center
  • West Virginia University Hospital
  • Hospital Italiano de La Plata
  • Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli
  • Sanatorio Britanico de Rosario
  • Sanatorio Parque de Rosario
  • Hospital Italiano de Buenos Aires
  • Hospital Iturraspe
  • St George Hospital
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Icon Cancer Care South Brisbane
  • Gold Coast University Hospital
  • Royal Adelaide Hospital
  • The Queen Elizabeth Hospital
  • Austin Health
  • The Alfred Hospital
  • Elisabethinen Hospital Linz
  • Salzburger Landeskliniken
  • Allgemeines Krankenhaus der Stadt Wien
  • Klinik Ottakring (fruher: Wilhelminenspital)
  • Centre Hospitalier Jolimont-Lobbes
  • Centre Hospitalier Universitaire Ambroise Pare
  • UZ Gent
  • AZ Sint-Jan AV
  • ZNA Middelheim
  • ZNA Stuivenberg
  • Hospital Das Clinicas Da Universidade Federal de Minas Gerais
  • Instituto de Oncologia Do Parana
  • Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
  • Hospital de Clinicas de Passo Fundo
  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
  • Mae de Deus Center Hospital Giovanni Battista
  • Centro de Pesquisas Oncologicas
  • Instituto Joinvilense de Hematologia E Oncologia
  • Hospital Amaral Carvalho
  • Hospital de Base Da FAMERP
  • Instituto Nacional de Cancer
  • Universidade Federal do Rio de Janeiro - UFRJ
  • Irmandade Da Santa Casa de Misericordia de Sao Paulo
  • Hospital Israelita Albert Einstein
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  • University Health Network
  • MUHC-Glen Site
  • Instituto Nacional de Cancerologia Colombia
  • Fundacion Valle Del Lili
  • Hospital Pablo Tobon Uribe
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Vseobecna Fakultni Nemocnice V Praze
  • Fakultni nemocnice Kralovske Vinohrady
  • Herlev Hospital
  • Aalborg Universitetshospital
  • Aarhus Universitetshospital Arhus Sygehus
  • Rigshospitalet
  • Odense Universitetshospital
  • Sjallands Universitetshospital, Roskilde
  • Vejle Sygehus
  • Hopital Antoine Beclere
  • Hotel Dieu - Nantes
  • CHRU Lille
  • Hopital Universitaire Dupuytren
  • Groupe Hospitalier Necker Enfants Malades
  • University Clinic Heidelberg
  • Klinikum Mannheim Universitatsklinikum gGmbH
  • Universitatsklinikum Ulm
  • LMU Klinikum der Universitat Munchen
  • Universitatsklinikum Wurzburg
  • Klinikum Darmstadt GmbH
  • Klinikum Frankfurt Hochst GmbH
  • Pius Hospital Oldenburg
  • Universitatsklinikum Bonn
  • Universitatsklinikum Essen
  • Evangelisches Krankenhaus Essen Werden gGmbH
  • Katholisches Krankenhaus Hagen gGmbH
  • Uniklinik Koln
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
  • Universitatsklinikum Carl Gustav Carus an der TU Dresden
  • Helios Klinikum Berlin-Buch
  • Charite - Universitatsmedizin Berlin
  • Asklepios Klinik St. Georg
  • Universitatsklinikum Hamburg Eppendorf
  • Asklepios Klinik Altona
  • KRH Klinikum Siloah-Oststadt-Heidehaus
  • Klinikum der Stadt Ludwigshafen gGmbH
  • Universitatsklinikum Tubingen
  • Evangelismos General Hospital of Athens
  • Laiko General Hospital of Athens
  • Alexandra Hospital
  • Georgios Papanikolaou General Hospital of Thessaloniki
  • Semmelweis Egyetem
  • Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet
  • Debreceni Egyetem Klinikai Kozpont
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Barzilai Medical Center
  • Soroka University Medical Centre
  • Bnai Zion Medical Center
  • Rambam Medical Center - PPDS
  • Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah Medical Center PPDS -
  • Galilee Medical Center
  • Rabin Medical Center - PPDS
  • Sheba Medical Center - PPDS
  • Kaplan Medical Center
  • ZIV Medical Center
  • Tel Aviv Sourasky Medical Center PPDS
  • Shamir Medical Center Assaf Harofeh
  • Presidio Ospedaliero di Pescara
  • Azienda Ospedaliera San Camillo Forlanini
  • Fondazione IRCCS Policlinico San Matteo di Pavia
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • IRCCS Centro Di Riferimento Oncologico Della Basilicata
  • Azienda Ospedaliera S Maria Di Terni
  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
  • Azienda Ospedaliera Universitaria Careggi
  • IRCCS Az. Osp. Universitaria San Martino- IST
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
  • Ospedale Infermi di Rimini
  • Kobe City Medical Center General Hospital
  • Iwate Medical University Hospital
  • National Hospital Organization Sendai Medical Center
  • Niigata Cancer Center Hospital
  • National Hospital Organization Okayama Medical Center
  • Saitama Medical Center
  • Juntendo University Hospital
  • Chiba University Hospital
  • Japanese Red Cross Medical Center
  • Keio University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Kyushu University Hospital
  • Nagoya City University Hospital
  • National Hospital Organization Nagoya Medical Center
  • National Hospital Organaization Shibukawa Medical Center
  • National Hospital Organization Disaster Medical Center
  • Toyohashi Municipal Hospital
  • National Cancer Center
  • Chungnam National University Hospital
  • Gachon University Gil Medical Center Pharmacy
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System - PPDS
  • Samsung Medical Center - PPDS
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Asan Medical Center - PPDS
  • Ewha Womans University Mokdong Hospital
  • Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • VU Medisch Centrum
  • Albert Schweitzer Ziekenhuis
  • Universitair Medisch Centrum Groningen
  • Erasmus MC
  • Universitair Medisch Centrum Utrecht
  • Vestre Viken HF Sykehuset Asker Og Barum
  • St. Olav's University Hospital
  • Oslo Universitetssykehus HF, Ulleval
  • Stavanger Universitetssykehus
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • Wojskowy Instytut Medyczny
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • Szpital Specjalistyczny w Brzozowie
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Hospital de Braga
  • Centro Hospitalar E Universitario de Coimbra EPE
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
  • Centro Hospitalar de Sao Joao, E.P.E.
  • National University Hospital
  • Singapore General Hospital (SGH)
  • Medical Oncology Centre of Rosebank
  • Mary Potter Oncology Centre
  • Albert Alberts Stem Cell Transplant Centre
  • Hospital Universitario Germans Trias i Pujol
  • Hospital General Universitario Gregorio Maranon
  • Clinica Universidad Navarra
  • Hospital Clinic de Barcelona
  • C.H. Regional Reina Sofia - PPDS
  • Institut Catala d'Oncologia Girona
  • Hospital Universitario de La Princesa
  • Hospital Universitario La Paz - PPDS
  • Hospital Universitario HM Sanchinarro CIOCC
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital General Universitario Morales Meseguer
  • Complejo Asistencial Universitario de Salamanca H. Clinico
  • Hospital Universitario Virgen del Rocio - PPDS
  • Helsingborg Lasarett
  • Skanes Universitetssjukhus Lund
  • Sahlgrenska Universitetssjukhuset
  • Karolinska Universitetssjukhuset Huddinge
  • Akademiska Sjukhuset I Uppsala
  • Universitatsspital Basel
  • Universitatsspital Zurich
  • Kaohsiung Medical University Hospital
  • Chang Gung Medical Foundation-Kaoshiung Branch
  • National Taiwan University Hospital
  • Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
  • Chang Gung Memorial Hospital, Linkou
  • Chulalongkorn University
  • Phramongkutklao Hospital
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
  • Ankara University Medical Faculty PPDS
  • Pamukkale Universitesi Tip Fakultesi Hastanesi
  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
  • Erciyes Universitesi Tip Fakultesi Hastanesi
  • Karadeniz Technical University Faculty of Medicine
  • MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council
  • Southampton General Hospital
  • Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
  • Kings College Hospital
  • Imperial College Healthcare NHS Trust
  • Churchill Hospital
  • Royal Marsden Hospital - Surrey
  • St James University Hospital
  • Royal Hallamshire Hospital
  • University Hospitals Leicester
  • University College London Hospitals (UCLH)
  • Singleton Hospital - PPDS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ixazomib Citrate

Placebo

Arm Description

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who have had any dose reductions due to adverse events (AEs) would not be dose escalated.

Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD), as evaluated by an independent review committee according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occured first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development.

Secondary Outcome Measures

Overall Survival (OS)
OS was measured as the time from the date of randomization to the date of death.
Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy
Response was assessed according to IMWG criteria. Best response includes PR, VGPR and CR. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by greater than or equal to (>=) 90% or to less than (<) 200 milligram (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry.
Time to Progression (TTP)
TTP is defined as the time from the date of randomization to the date of first documentation of PD , using IMWG criteria. PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.
Second Progression Free Survival (PFS2)
PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.
Time to Start of the Next Line of Therapy
Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first.
Time to End of the Next Line of Therapy
Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first.
Duration of the Next Line of Therapy
Duration of the next line of therapy is defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurs first. Duration of the next line of therapy will be analyzed on those participants who actually received the next line of therapy following the study treatment and duration would be summarized using Kaplan-Meier method. Participants who are still on treatment on the next line of therapy will be censored at last visit.
Percentage of Participants Who Develop A New Primary Malignancy
Number of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative, and Maintenance of MRD Negativity
MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The conversion rate from MRD positive to MRD negative and the maintenance of MRD negativity will be assessed and reported. Bone marrow aspirates and blood samples will be sent to a central laboratory and will be assessed for MRD using flow cytometry and a sequencing methodology.
Correlation Between MRD Status and Progression Free Survival (PFS) and Overall Survival (OS)
Degree of correlation will be determined between 2 methodologies for MRD assessment (8-color flow cytometry, next-generation sequencing and bone marrow aspirates and blood samples). Association between MRD status with PFS and OS will be evaluated independently from the methodology used for the assessment. The association between MRD status and PFS and OS will be evaluated in both study arms, and concordance between flow cytometry and sequencing readouts will be assessed.
OS Benefits in a High-Risk Population
High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS will be measured as the time from the date of randomization to the date of death.
PFS Benefits in a High-Risk Population
High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS is defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.
Eastern Cooperative Oncology Group (ECOG) Performance Score
The ECOG performance is a 6-point scale used by doctors to assess how a participant's disease is progressing, how the disease affects the participant's daily life, and to determine appropriate treatment and prognosis. The scale is 0=Normal activity. Fully active, able to carry on all pre disease performance without restriction (best) to 5=Dead.
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs)
Number of Participants With Markedly Abnormal Clinical Laboratory Values
Health-related Quality of Life (HRQL) Score Based on The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Domain
EORTC QLQ-C30 is completed by the participants. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best).
Plasma Concentration of Ixazomib
Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) will be measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay.
Time to Resolution of Peripheral Neuropathy (PN) Events
Peripheral neuropathy is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.
Time to Improvement of PN Events
PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.

Full Information

First Posted
June 27, 2014
Last Updated
August 30, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02181413
Brief Title
A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
Official Title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
Detailed Description
The investigational drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have NDMM and who have had any type of positive response to induction therapy followed by HDT and ASCT. This study will look at the effect ixazomib citrate has on the length of time that participants are free of progressive disease (PD) and their overall survival (OS). The study enrolled 656 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need, or if the disease has progressed and the information is required for planning the next treatment): Ixazomib citrate 3 mg for the first 4 cycles, then 4 mg for the remaining 22 cycles Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient. All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles (approximately 24 months). This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits after treatment has ended. During this initial follow up period, participants will be assessed for disease status with follow up every 12 weeks. After the next line of therapy begins, follow-up will occur every 12 weeks until death or termination of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Autologous Stem Cell Transplant
Keywords
Drug therapy, Ixazomib citrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ixazomib Citrate
Arm Type
Experimental
Arm Description
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons. Participants who have had any dose reductions due to adverse events (AEs) would not be dose escalated.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons.
Intervention Type
Drug
Intervention Name(s)
Ixazomib Citrate
Other Intervention Name(s)
MLN9708
Intervention Description
Ixazomib citrate capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ixazomib citrate placebo-matching capsules
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD), as evaluated by an independent review committee according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occured first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development.
Time Frame
Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks until progression of disease or death (to data cutoff: approximately 4 years)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was measured as the time from the date of randomization to the date of death.
Time Frame
Baseline up to Follow up period (107 months)
Title
Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy
Description
Response was assessed according to IMWG criteria. Best response includes PR, VGPR and CR. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by greater than or equal to (>=) 90% or to less than (<) 200 milligram (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry.
Time Frame
Baseline up to EOT (24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 months)
Title
Time to Progression (TTP)
Description
TTP is defined as the time from the date of randomization to the date of first documentation of PD , using IMWG criteria. PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.
Time Frame
Baseline until PD (Month 107)
Title
Second Progression Free Survival (PFS2)
Description
PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.
Time Frame
Baseline up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to Month 107)
Title
Time to Start of the Next Line of Therapy
Description
Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first.
Time Frame
Baseline up to start of next line of therapy (after 24 months treatment period followed by every 4 weeks PFS and PD follow up period)
Title
Time to End of the Next Line of Therapy
Description
Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first.
Time Frame
Baseline up to end of next line of therapy (Month 107)
Title
Duration of the Next Line of Therapy
Description
Duration of the next line of therapy is defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurs first. Duration of the next line of therapy will be analyzed on those participants who actually received the next line of therapy following the study treatment and duration would be summarized using Kaplan-Meier method. Participants who are still on treatment on the next line of therapy will be censored at last visit.
Time Frame
From the start of next line therapy after PD to the last dose of next line therapy (up to Month 107)
Title
Percentage of Participants Who Develop A New Primary Malignancy
Time Frame
Baseline until death or termination of the study (up to Month 107)
Title
Number of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative, and Maintenance of MRD Negativity
Description
MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The conversion rate from MRD positive to MRD negative and the maintenance of MRD negativity will be assessed and reported. Bone marrow aspirates and blood samples will be sent to a central laboratory and will be assessed for MRD using flow cytometry and a sequencing methodology.
Time Frame
Baseline up to EOT (24 months)
Title
Correlation Between MRD Status and Progression Free Survival (PFS) and Overall Survival (OS)
Description
Degree of correlation will be determined between 2 methodologies for MRD assessment (8-color flow cytometry, next-generation sequencing and bone marrow aspirates and blood samples). Association between MRD status with PFS and OS will be evaluated independently from the methodology used for the assessment. The association between MRD status and PFS and OS will be evaluated in both study arms, and concordance between flow cytometry and sequencing readouts will be assessed.
Time Frame
Baseline up to Month 107
Title
OS Benefits in a High-Risk Population
Description
High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS will be measured as the time from the date of randomization to the date of death.
Time Frame
Randomization up to Month 107
Title
PFS Benefits in a High-Risk Population
Description
High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS is defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.
Time Frame
Randomization up to Month 107
Title
Eastern Cooperative Oncology Group (ECOG) Performance Score
Description
The ECOG performance is a 6-point scale used by doctors to assess how a participant's disease is progressing, how the disease affects the participant's daily life, and to determine appropriate treatment and prognosis. The scale is 0=Normal activity. Fully active, able to carry on all pre disease performance without restriction (best) to 5=Dead.
Time Frame
Baseline up to EOT (24 months), thereafter every 4 weeks until initiation of next line therapy
Title
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs)
Time Frame
First dose of study drug through 30 days after last dose of study drug (up to 24 months)
Title
Number of Participants With Markedly Abnormal Clinical Laboratory Values
Time Frame
Baseline through 30 days after the last dose of study drug (up to 24 months)
Title
Health-related Quality of Life (HRQL) Score Based on The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Domain
Description
EORTC QLQ-C30 is completed by the participants. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best).
Time Frame
Baseline up to PD (up to Month 107)
Title
Plasma Concentration of Ixazomib
Description
Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) will be measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay.
Time Frame
Day 1 of Cycle 1 at multiple time points (up to 4 hours) post-dose; Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle of 28 days) predose
Title
Time to Resolution of Peripheral Neuropathy (PN) Events
Description
Peripheral neuropathy is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.
Time Frame
From randomization date through 30 days after the last dose of drug (up to 24 months)
Title
Time to Improvement of PN Events
Description
PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.
Time Frame
From randomization date through 30 days after the last dose of drug (up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria. Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available. Underwent standard of care (SOC) induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], and dexamethasone (VAD) is not an acceptable induction therapy for this trial. Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant. Must have not received post-ASCT consolidation therapy. Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria. ECOG performance status of 0 to 2. Female participants who: If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, AND Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, AND Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. Suitable venous access for the study-required blood sampling. Is willing and able to adhere to the study visit schedule and other protocol requirements. Must meet the following clinical laboratory criteria at study entry: Absolute neutrophil count (ANC) ≥ 1,000 per cubic milliliter (/mm^3) and platelet count ≥ 75,000/mm^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization. Total bilirubin ≤ 1.5 * the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 * ULN. Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min). Exclusion Criteria: Multiple myeloma that has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy. Double (tandem) ASCT. Radiotherapy within 14 days before the first dose of study drug. Diagnosed or treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period. Major surgery within 14 days before randomization. Central nervous system involvement. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization. Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause). Psychiatric illness/social situation that would limit compliance with study requirements. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment. Treatment with any investigational products within 60 days before the first dose of the study drug regimen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mayo Clinic - PPDS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AX
Country
Argentina
Facility Name
Instituto de Hematologia Y Medicina Clinica Dr Ruben Davoli
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio Britanico de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Sanatorio Parque de Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Iturraspe
City
Santa Fe
ZIP/Postal Code
S3006FTP
Country
Argentina
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Elisabethinen Hospital Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Salzburger Landeskliniken
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinik Ottakring (fruher: Wilhelminenspital)
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Centre Hospitalier Jolimont-Lobbes
City
La Louviere
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Ambroise Pare
City
Mons
State/Province
Hainaut
ZIP/Postal Code
7000
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Jan AV
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Hospital Das Clinicas Da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Instituto de Oncologia Do Parana
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80530-010
Country
Brazil
Facility Name
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Hospital de Clinicas de Passo Fundo
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Mae de Deus Center Hospital Giovanni Battista
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Centro de Pesquisas Oncologicas
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034000
Country
Brazil
Facility Name
Instituto Joinvilense de Hematologia E Oncologia
City
Joinville
State/Province
Santa Catarina
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
Hospital Amaral Carvalho
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Hospital de Base Da FAMERP
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional de Cancer
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro - UFRJ
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Irmandade Da Santa Casa de Misericordia de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
5403000
Country
Brazil
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
MUHC-Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Instituto Nacional de Cancerologia Colombia
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Fundacion Valle Del Lili
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
Country
Colombia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
State/Province
Kralovehradeck Kraj
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice V Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Herlev Hospital
City
Herlev
State/Province
Capital
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aalborg Universitetshospital
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Name
Aarhus Universitetshospital Arhus Sygehus
City
Aarhus N
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sjallands Universitetshospital, Roskilde
City
Roskilde
ZIP/Postal Code
DK-4000
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark
Facility Name
Hopital Antoine Beclere
City
Clamart
State/Province
Hauts-de-Seine
ZIP/Postal Code
92140
Country
France
Facility Name
Hotel Dieu - Nantes
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
CHRU Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Universitaire Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Groupe Hospitalier Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
University Clinic Heidelberg
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum Mannheim Universitatsklinikum gGmbH
City
Mannheim
State/Province
Baden-Wurttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
LMU Klinikum der Universitat Munchen
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Wurzburg
City
Wurzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Klinikum Darmstadt GmbH
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Facility Name
Klinikum Frankfurt Hochst GmbH
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
Facility Name
Pius Hospital Oldenburg
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26121
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Evangelisches Krankenhaus Essen Werden gGmbH
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Katholisches Krankenhaus Hagen gGmbH
City
Hagen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Uniklinik Koln
City
Koln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
1307
Country
Germany
Facility Name
Helios Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitatsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
KRH Klinikum Siloah-Oststadt-Heidehaus
City
Hannover
ZIP/Postal Code
30459
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen gGmbH
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitatsklinikum Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Evangelismos General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
10676
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Georgios Papanikolaou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz- Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka University Medical Centre
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center - PPDS
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center PPDS -
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center - PPDS
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center - PPDS
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
ZIV Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center PPDS
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Shamir Medical Center Assaf Harofeh
City
Tzrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Presidio Ospedaliero di Pescara
City
Pescara
State/Province
Abruzzo
ZIP/Postal Code
65100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
152
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo di Pavia
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
City
Ancona
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
IRCCS Centro Di Riferimento Oncologico Della Basilicata
City
Rionero In Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Facility Name
Azienda Ospedaliera S Maria Di Terni
City
Terni
State/Province
Umbria
ZIP/Postal Code
5100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
IRCCS Az. Osp. Universitaria San Martino- IST
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Infermi di Rimini
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-City
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9838520
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama-City
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe-city
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
State/Province
Tokyo
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-City
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya-City
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organaization Shibukawa Medical Center
City
Shibukawa
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tachikawa
ZIP/Postal Code
1900014
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi-City
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggido
ZIP/Postal Code
410769
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center Pharmacy
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158710
Country
Korea, Republic of
Facility Name
Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
VU Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Vestre Viken HF Sykehuset Asker Og Barum
City
Gjelta
State/Province
Oppland
ZIP/Postal Code
N-1346
Country
Norway
Facility Name
St. Olav's University Hospital
City
Trondheim
State/Province
Sor-Trondelag
ZIP/Postal Code
N-7030
Country
Norway
Facility Name
Oslo Universitetssykehus HF, Ulleval
City
Oslo
ZIP/Postal Code
450
Country
Norway
Facility Name
Stavanger Universitetssykehus
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
City
Chorzow
State/Province
Slaskie
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Szpital Specjalistyczny w Brzozowie
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar E Universitario de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital (SGH)
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Medical Oncology Centre of Rosebank
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Mary Potter Oncology Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
181
Country
South Africa
Facility Name
Albert Alberts Stem Cell Transplant Centre
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
44
Country
South Africa
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
State/Province
Madrid, Communidad Delaware
ZIP/Postal Code
28009
Country
Spain
Facility Name
Clinica Universidad Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
C.H. Regional Reina Sofia - PPDS
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Institut Catala d'Oncologia Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro CIOCC
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca H. Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Helsingborg Lasarett
City
Helsingborg
State/Province
Skane Lan
Country
Sweden
Facility Name
Skanes Universitetssjukhus Lund
City
Lund
State/Province
Skane Lan
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
State/Province
Vastra Gotalands Lan
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Akademiska Sjukhuset I Uppsala
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
Universitatsspital Basel
City
Basel
State/Province
Basel-Stadt (de)
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
State/Province
Zurich (de)
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-Kaoshiung Branch
City
Kaohsiung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
613
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chulalongkorn University
City
Bangkok
State/Province
Krung Thep Maha Nakhon-Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
State/Province
Krung Thep Maha Nakhon-Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
City
Ankara
ZIP/Postal Code
6200
Country
Turkey
Facility Name
Ankara University Medical Faculty PPDS
City
Ankara
Country
Turkey
Facility Name
Pamukkale Universitesi Tip Fakultesi Hastanesi
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Erciyes Universitesi Tip Fakultesi Hastanesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Karadeniz Technical University Faculty of Medicine
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
MNPE Kyiv Center of Bone Marrow Transplantation of executive body of Kyiv council
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
Facility Name
Southampton General Hospital
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Surrey
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
University Hospitals Leicester
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
University College London Hospitals (UCLH)
City
London
ZIP/Postal Code
WC1E 6AG
Country
United Kingdom
Facility Name
Singleton Hospital - PPDS
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
32613281
Citation
Kaiser M, Beksac M, Gulbrandsen N, Schjesvold F, Hajek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1. Erratum In: Ann Hematol. 2021 Jan;100(1):297-302.
Results Reference
derived
PubMed Identifier
31880006
Citation
Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22.
Results Reference
derived
PubMed Identifier
30545780
Citation
Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.
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A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

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